S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

SWOG Cancer Research Network

Status and phase: Completed; Phase 2

Conditions: Adult Meningioma

Treatments: Drug: hydroxyurea

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00003590

CDR0000066659

S9811 (Other Identifier)

ECOG-S9811 (Other Identifier)

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy such as hydroxyurea use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.

Full description

OBJECTIVES:

• Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea.
• Assess the quantitative and qualitative toxic effects of this drug in this patient population.

OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.

Enrollment: 29 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed unresectable primary, recurrent, or residual benign meningioma
• Measurable disease by CT scan or MRI
• Must have disease progression within the past 10 years OR progressive neurologic deficit within the past 6 months
• Must have undergone prior radiotherapy with subsequent disease progression OR refused radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3
• Platelet count at least lower limit of normal

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior cytotoxic chemotherapy for meningioma
• Prior mifepristone allowed
• No other concurrent chemotherapy

Endocrine therapy:

• Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to CT scan or MRI
• No concurrent antitumor hormonal therapy

Radiotherapy:

• See Disease Characteristics
• At least 6 months since prior radiotherapy
• No concurrent radiotherapy

Surgery:

• Not specified

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Hydroxyurea

Experimental group

Treatment:

Drug: hydroxyurea